Posted by Michael Wonder on 18 Jul 2022
EMA validates marketing authorisation application for trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
18 July 2022 - Submission follows positive results of Phase 3 TULIP trial.
Byondis announced today that the EMA has validated the marketing authorisation application for the company's investigational next generation anti-HER2 antibody-drug conjugate trastuzumab duocarmazine (SYD985) in patients with HER2 positive unresectable locally advanced or metastatic breast cancer.
